18. 1 Definitions
18. 1.1 Conflict of Interest (COI)
COI is a set of conditions in which professional judgment concerning a primary interest (such as patients’ welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)”.7
COI may also be defined as a set of conditions where professional judgement concerning a primary interest such as participant’s welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or non-financial (personal, academic or political). COI can be at the level of researchers, EC members, institutions or sponsors.8
Situations where Conflict of Interest may arise when an IRB member, Investigator, research staff, or member of his/her immediate family:
- has or will receive from the sponsor of the research financial or other form(s) of compensation; or
- has a significant financial interest in the company/agency/firm that is sponsoring the research; or
- discloses a conflict of interest to the governmental agency, or to the Institution or
18.1.2 Immediate Family: An IRB member, or Investigator’s spouse or domestic partner, children and anyone who resides with the IRB member, Investigator, or research staff.
18.1.3 Significant Financial Interest: Anything of major monetary value, including but not limited to salary or other payment for services (e.g. consulting fees or honoraria); and intellectual property (e.g. patents, copyrights, and royalties from such rights).
18.2.1 Disclosure and Documentation of Financial Interest and COI
- The IRB will maintain a documented record of membership lists, lists of occupations/affiliations of members will be maintained.
- The IRB Chairperson or designee will ask IRB members for COI disclosure prior to each IRB Meeting.
- No IRB member may participate in the review of any project in which he or she has a conflicting interest, except to provide information requested by the IRB.
- Any disclosure of IRB member COI will be discussed prior to the deliberation of studies at each IRB Meeting. The IRB member may be asked to leave the meeting room during the formal discussion and voting on a research proposal where there is COI.
- An investigator may be a member of an IRB. The investigator has to submit a disclosure of interest document that may affect the research, if any to the IRB. However, the investigator cannot participate in the review or approval of any research in which he or she has a current or potential conflict of interest. The investigator should be absent from the meeting room while the IRB discusses and votes on the research in which he or she has an interest.
- The IRB Secretary will record any identified COI in the IRB meeting minutes.
18.2.1 In case of disclosed COI prior to IRB review
The investigator will be required to provide the following:
- Description of the relationship between investigator and/or immediate family with the sponsor of the research
- Statement in the informed consent form that addresses the conflict of interest, if required.
- Justification for exclusion of conflict of interest in the informed consent
18.2.2 In case of a COI developing after the IRB approval
The investigator will be required to:
- Inform the IRB chairperson or designee of the COI disclosure.
- Submit the COI disclosure as an Amendment (revision) to the approved research protocol, and include a revised informed consent form that includes a statement addressing any potential conflict of interest, if appropriate.
- The IRB may require that COIs be disclosed in the informed consent, that the Investigator or research staff member recuse him/herself as the principal Investigator (or part of the research staff, respectively), or from the study entirely.